Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)

This study will randomize 60 participants with moderate to severe Insomnia to one of two treatments over the course of 6 weeks: 1) a wearable device that uses Acoustic Resonance Therapy (ART) or 2) the interactive learning module - Cognitive Behavioral Therapy for Insomnia (CBT-I).

Inclusion criteria

• Adult subjects, 22 years of age and older at screening
• Moderate-to-severe insomnia disorder, as defined by the International Classification of Sleep Disorders (ICSD-3)* and the Insomnia Severity Index (ISI) and have been diagnosed for more than three months.
• Not pregnant by subject self-report at time of consent.
• Have the ability to provide informed consent.
• Have the ability to complete all aspects of this trial.
• Have access to an iOS mobile device (iPhone X or above).
• Have no contraindicating comorbid health condition that would interfere with the proper use of the SONU Headband system, as determined by the clinical investigators.
• Participants who are taking sleep-aiding pills must agree to no changes to medication and dosage during the study.

• According to the third edition of the International Classification of Sleep Disorders (ICSD-3), insomnia is characterized by difficulty in either initiating sleep, maintaining sleep continuity, or poor sleep quality

Exclusion criteria

• Patients who are unable to commit to avoiding the consumption of alcohol during the study.
• Patients who are unable to commit to avoid consumption of caffeine after 12 pm (noon).
• Patients who have a clinically significant or unstable medical or surgical condition.
• Participants using pacemakers or cardiac monitors.
• Participants with severe physical illness or immediately post-surgery
• Participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases such as a seizure, stroke, or Parkinson's disease.
• Participants with other serious sleep disorders, such as severe obstructive sleep apnea.
• Participants who are unable to attend regular follow-up evaluations.
• Any unstable medical or mental health condition as determined by the physician investigator.